# The Human Medicines Regulations 2012, Paragraph 12


The manufacturer must inform the holder of the UK marketing authorisation of any material change since the day upon which the authorisation was granted in respect of—
(a) the facilities and equipment available at each of the premises of the manufacturer for carrying out any stage of the manufacture or assembly of the medicinal products to which the UK marketing authorisation relates;
(b) the facilities and equipment available at each of the premises of the manufacturer for the storage of the medicinal products to which the UK marketing authorisation relates on, and the distribution of the products from or between, such premises;
(c) any manufacturing operations, not being operations in relation to the medicinal products to which the UK marketing authorisation relates, which are carried on by the manufacturer on or near any of the premises on which medicinal products to which the UK marketing authorisation relates are manufactured or assembled, and the substances or articles in respect of which such operations are carried on;
(d) the arrangements for the identification and storage of materials and ingredients before and during manufacture or assembly of the medicinal products to which the UK marketing authorisation relates and the arrangements for the storage of the products after they have been manufactured or assembled;
(e) the arrangements for ensuring a satisfactory turnover of stocks of medicinal products to which the UK marketing authorisation relates;
(f) the arrangements for maintaining production records and records of analytical and other testing procedures applied in the course of manufacture or assembly of the medicinal products to which the UK marketing authorisation relates; or
(g) the arrangements for keeping reference samples of materials used in the manufacture of the medicinal products to which the UK marketing authorisation relates and reference samples of the medicinal products themselves.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/9/paragraph/12 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-9/paragraph-12
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.